12 January - 20 June 2016

Legislation headlines

  • Application for registering a name in the register of protected geographical indications (‘Czosnek galicyjski’ (PGI))
  • Application for registering a name in the register of protected geographical indications (‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ (PGI))
  • Application for approval of non-minor amendments to the product specification for a protected geographical indication ‘Boudin Blanc De Rethel’
  • Entering a name in the register of protected geographical indications (‘Beelitzer Spargel’ (PGI))
  • Permitted health claim – Energy drinks
  • Entering a name in the register of protected geographical indications (‘Amêndoa Coberta de Moncorvo’ (PGI))
  • Procedural steps of the consultation process for determination of novel food status
  • Authorising an extension of use of L-ergothioneine as a novel food
  • Authorising an extension of use of taxifolin-rich extract as a novel food
  • Authorising the placing on the market of Ecklonia cava phlorotannins as a novel food
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Moules de bouchot de la Baie du Mont-Saint-Michel’ (PDO))
  • Application for approval of non-minor amendments to the product specification for a protected geographical indication (‘Brioche Vendéenne’)
  • Approval of minor amendments to the specification for  ‘Ail blanc de Lomagne’ to enter the register of protected geographical indication (PGI)
  • The non-approval of the active substance Reynoutria sachalinensis extract
  • Application for registering a name in the register of protected geographical indications (Marrone di Serino’/‘Castagna di Serino’(PGI))
  • Application for approval of an amendment to the product specification of protected designations of origin (Oli de l’Empordà’/‘Aceite de L’Empordà (PDO))
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Squacquerone di Romagna (PDO))
  • Entering a name in the register of protected geographical indications (‘Thym de Provence’ (PGI))
  • Application for approval of an amendment to the product specification of (‘Kiwi Latina’ (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Salchichón de Vic’/‘Llonganissa de Vic’ (PGI))
  • Maximum levels of glycidyl fatty acid esters in vegetable oils and fats, infant formula, follow-on formula and foods for special medical purposes intended for infants and young children
  • Scientific opinions

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Marrone del Mugello’ (PGI))
The Commission has examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Marrone del Mugello’.  Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification have been approved.

Application for registering a name in the register of protected geographical indications (‘Czosnek galicyjski’ (PGI))
Poland have applied for the name ‘Czosnek galicyjski’ to enter the register of protected geographical indications. The name ‘Czosnek galicyjski’ applies to fresh bulbs of common garlic (Allium sativum L.). It refers to garlic produced by cultivation of the ‘Harnaś’ and ‘Arkus’ varieties.

Application for registering a name in the register of protected geographical indications (‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ (PGI))
Germany have applied for ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ to enter the register of protected geographical indications.  ‘Bayrisch Blockmalz’ is a hard-boiled sweet or candy, with a malty flavour produced by malt extract. These dark brown sweets weigh between 3 g and 9 g and, due to the way they are produced, have an irregular, more-or-less cube-like although also rounded shape. The sugar/syrup composition of ‘Bayrisch Blockmalz’ contains sugar caramel from various types of sugar and at least 5 % malt extract or 4 % dried malt extract.

Application for approval of non-minor amendments to the product specification for a protected geographical indication ‘Boudin Blanc De Rethel’
France have made amendments to their application for Boudin Blanc De Rethel to enter the register of protected geographical indications.  Amendments have been made to the description of the product, proof of origin, method of production, labelling and other. 

Entering a name in the register of protected geographical indications (‘Beelitzer Spargel’ (PGI))
Germany's application to register the name ‘Beelitzer Spargel’ was published in the Official Journal of the European Union.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Beelitzer Spargel’ should therefore be entered in the register.

Permitted health claim – Energy drinks
According to Article 2(5) of Regulation (EC) No 1924/2006, a ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. There are legitimate concerns that the claims that caffeine helps to increase alertness and that caffeine helps to improve concentration do not demonstrate a relationship between caffeine consumption and ‘health’.  A 250 ml can of energy drink can contain up to 27 g of sugar and 80 mg of caffeine. The World Health Organisation recommends that adults and children receive no more than 10 % of their daily energy intake from free sugars and that a further reduction to below 5 % (approximately 25 g) per day would provide additional health benefits. EFSA found evidence that a high intake of sugars in the form of sugar-sweetened beverages might contribute to weight gain.  The use of the proposed health claims is likely to favour the consumption of energy drinks and, as a consequence, the daily intake of sugar and caffeine might legitimately be expected to exceed the recommended maximum daily intake.  Energy drinks have been linked to headaches, sleep problems and behavioural problems in children and adolescents who regularly consume them.  The draft Commission regulation is not compatible with the aim and content of Regulation (EC) No 1924/2006 and calls on the Commission to withdraw the draft regulation.  It calls on the Member States to consider introducing rules on the marketing of beverages with high caffeine content or foods with added caffeine to children and adolescents and instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

Entering a name in the register of protected geographical indications (‘Amêndoa Coberta de Moncorvo’ (PGI))
Portugal's application to register the name ‘Amêndoa Coberta de Moncorvo’ was published in the Official Journal of the European Union. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Amêndoa Coberta de Moncorvo’ should therefore be entered in the register.

Procedural steps of the consultation process for determination of novel food status
Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union. Article 4 of Regulation (EU) 2015/2283 lays down basic principles on the procedure for the determination of novel food status. Paragraph 1 of that Article requires food business operators to verify whether or not the food which they intend to place on the Union market falls within the scope of that Regulation. In order to determine the novel food status of a particular food, a consultation request should be submitted. The Member States should verify the validity of such requests. Therefore, it is necessary to establish rules for the verification process. Rules should be established in order to ensure that the consultation request for determination of novel food status provides all the information necessary for the evaluation by the Member States. In order to ensure that food business operators and the public are informed of the novel food status, the information on the novel food status should be made publicly available. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

Authorising an extension of use of L-ergothioneine as a novel food
On 25 July 2013, the company Tetrahedron made a request to the competent authority of France to place synthetic L-ergothioneine (‘L-ergothioneine’) on the Union market as a novel food ingredient The application requested for L-ergothioneine to be used in food supplements for the general population excluding pregnant and lactating women and for children older than three years, and in non-alcoholic beverages, fresh milk products, milk based drinks, cereal bars and chocolate for the general population excluding pregnant and lactating women, infants and young children. EFSA opinion is that gives sufficient grounds to establish that L-ergothioneine when used as an ingredient in non-alcoholic beverages, fresh milk products, milk-based drinks, cereal bars and chocolate confectionery taking into account all population groups, complies with Article 12(1) of Regulation (EU) 2015/2283.

Authorising an extension of use of taxifolin-rich extract as a novel food
In 23 August 2010, the company Ametis JSC made a request to the competent authority of the United Kingdom to place taxifolin-rich extract from the wood of Dahurian larch (Larix gmelinii (Rupr.) Rupr) on the Union market as a novel food ingredient. The application requested for taxifolin-rich extract to be used in food supplements for a population older than fourteen years, and in non-alcoholic beverages, yogurt and chocolate confectionery for the general population excluding infants, young children and children up to 9 years. EFSA opinion gaves sufficient grounds to establish that taxifolin-rich extract when used as an ingredient in non-alcoholic beverages, milk products and chocolate confectionery taking into account all population groups, complies with Article 12(1) of Regulation (EU) 2015/2283. Regulation (EU) No 1308/2013 lays down requirements for milk and milk products which apply to taxifolin-rich extract when used as an ingredient in milk products. Pursuant to its point 2 of Part III of Annex VII taxifolin-rich extract cannot be used in milk products to replace, in whole or in part, any milk constituent. The use of taxifolin-rich extract as a novel food in milk products therefore has to be limited accordingly.

Authorising the placing on the market of Ecklonia cava phlorotannins as a novel food
On 14 May 2015, the company Botamedi Inc. made a request to the competent authority of Ireland to place phlorotannins extracted from the edible marine alga Ecklonia cava (‘Ecklonia cava phlorotannins’) on the Union market as a novel food ingredient. The application requests for Ecklonia cava phlorotannins to be used in food supplements for the general population, excluding children below 12 years of age. The competent authority of Ireland issued its initial assessment report. In that report it came to the conclusion that an additional assessment is required for Ecklonia cava phlorotannins.  The EFSA carrying out an additional assessment and reported that iodine intake from food supplements containing Ecklonia cava phlorotannins may be of concern for people at risk of thyroid disease, and that, if people who are not at risk of thyroid disease take food supplements containing Ecklonia cava phlorotannins in addition to other food supplements containing iodine, their overall iodine intake may exceed the upper limit established for iodine. Food supplements containing Ecklonia cava phlorotannins should therefore be appropriately labelled. Moreover, taking into account the intended use and the fact that the request for authorisation excludes children under the age of 12 years, food supplements containing Ecklonia cava phlorotannins should also be appropriately labelled in this regard. It follows, that the EFSA opinion gives sufficient grounds to establish that Ecklonia cava phlorotannins in the proposed uses and use levels when used as an ingredient in food supplements, complies with Regulation (EU) 2015/2283 and therefore is approved.

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Moules de bouchot de la Baie du Mont-Saint-Michel’ (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Moules de bouchot de la Baie du Mont-Saint-Michel’.  As no statement of opposition has been received by the Commission, the amendments to the specification have been approved.

Application for approval of non-minor amendments to the product specification for a protected geographical indication (‘Brioche Vendéenne’)
France have applied for approval of non-minor amendement to their product specification for ‘Brioche Vendéenne’. Amendments have been made to the description of the product, proof of origin, method of production, link, and labelling.  ‘Brioche vendéenne’ is a brioche which is braided and golden on its upper side, available in a regular round, oval or loaf shape. It is always marketed fresh, whole or sliced, on food-quality paper and bagged. It has a minimum weight of 300 grams.

Approval of minor amendments to the specification for  ‘Ail blanc de Lomagne’ to enter the register of protected geographical indication (PGI)
France have submited amendments to the specificaiton for Ail blanc de Lomagen.  Amendments have been made to production method and other. ‘Ail blanc de Lomagne’ is garlic with white to ivory white bulbs, sometimes streaked with violet, made up of several cloves (8 to 12 depending on the size). It is characterised by the bulb's round and regular shape.

The non-approval of the active substance Reynoutria sachalinensis extract
The United Kingdom received an application from Marrone Bio innovations for the approval of the active substance Reynoutria sachalinensis extract who notified the commission and other member states. The effects on human and animal health and the environment have been assessed by the EFSA  and presented to the commission. However Marrone Bio innovations withdrew its application for the approval of Reynoutria sachalinensis extract. Due to the withdrawal of the application, Reynoutria sachalinensis extract should not be approved. This Regulation does not prejudice the submission of a further application for Reynoutria sachalinensis extract.

Application for registering a name in the register of protected geographical indications (Marrone di Serino’/‘Castagna di Serino’(PGI))
Italy have applied for Marrone di Serino/Castagna di Serino to enter the register of protected geographical indications.  ‘Marrone di Serino’/‘Castagna di Serino’ designates the fresh, peeled, dried in-shell and whole dried shelled fruit of the ‘Castanea Sativa Miller’ or ‘European chestnut’ species, of the ‘Montemarano’ variety.

Application for approval of an amendment to the product specification of protected designations of origin (Oli de l’Empordà’/‘Aceite de L’Empordà (PDO))
Spain have applied for approval of their amendments to the specification for Oli de l’Empordà’.  Amendments have been made to the products description, and legal requirements.  The requested amendment is the removal of an analytical parameter (total polyphenol content) from the physico-chemical characteristics of oils covered by the PDO ‘Oli de l’Empordà’/‘Aceite de L’Empordà’. This amendment does not alter or change the quality and characteristics of the oils in any way.

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Squacquerone di Romagna (PDO))
The Commission has examined Italy's application for the approval of amendments to the specification for the protected designation of origin ‘Squacquerone di Romagna’.  The Commission published the amendment application in the Official Journal of the European Union and as no statement of opposition has been received, the amendments to the specification have been approved.

Entering a name in the register of protected geographical indications (‘Thym de Provence’ (PGI))
The application from France to register the name ‘Thym de Provence’ as protected geographical indication (PGI) was published in the Official Journal of the European Union.  The Commission received the notice of opposition and the related reasoned statement of opposition from Germany. The Commission forwarded the notice of opposition and the reasoned statement of opposition sent by Germany to France.  Germany opposed to the registration of the name ‘Thym de Provence’ because it would jeopardise the use of the term ‘Herbes de Provence’ (‘Kräuter der Provence’ in German) commonly used in spice- and seasoning-making to describe a type-defined mixture of herbs, normally containing, among others, rosemary, oregano, thyme, sage and lavender, but also bay leaf and other spices such as nutmeg and cloves, in various combinations. While the mixture of herbs called ‘Herbes de Provence’ contains typical Provençal herbs, it also contains other spices such as bay and nutmeg which are not typical of Provence. In addition, ‘Herbes de Provence’ is made with herbs which do not necessarily originate from Provence. The registration of the name ‘Thym de Provence’ therefore might jeopardise the marketing of the entire mixture of herbs and spices as ‘Herbes de Provence’.  France and Germany agreed that even after the registration of the designation ‘Thym de Provence’ as PGI the use of the term ‘Herbes de Provence’, including its translations, should continue to be allowed within the territory of the Union provided the principles and rules applicable in its legal order are respected. In the light of the above, the name ‘Thym de Provence’ should be entered in the Register of protected designations of origin and protected geographical indications.

Application for approval of an amendment to the product specification of (‘Kiwi Latina’ (PGI))
Italy have applied for approval of amendment to their product specification for PGI Kiwi Latina.  Amendments have been made to the description of the product, proof of origin, link and other. Kiwi Latina is a fruit which is an elliptical cylinder, greater in length than diameter, with light brown skin against a light green background, a soft tomentum, and a calyx that lies slightly below the shoulders. Its flesh is light emerald green in colour with a soft whitish core surrounded by a ring of numerous small black seeds.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Salchichón de Vic’/‘Llonganissa de Vic’ (PGI))
The Commission has examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Salchichón de Vic’/‘Llonganissa de Vic’.  The Commission published the amendment application in the Official Journal of the European Union and as no statement of opposition was received the amendments have been approved.

Maximum levels of glycidyl fatty acid esters in vegetable oils and fats, infant formula, follow-on formula and foods for special medical purposes intended for infants and young children
In May of 2016, the Scientific Panel on Contaminants in the Food Chain (Contam) of the European Food Safety Authority adopted a scientific opinion on the Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA concluded that glycidol is a genotoxic and carcinogenic compound. In view of the genotoxic and carcinogenic potential of glycidol, the Authority applied a margin of exposure (‘MoE’) approach. Scenarios of exposure for infants, toddlers and other children resulted in a MoE ranging from 12 800 to 4 900 and for infants receiving only formula diet in a MoE of about 5 500 to 2 100. The Authority considered that a MoE lower than 25 000 is of health concern. It is therefore appropriate to establish a maximum level for the presence of glycidyl fatty acid esters in vegetable oils and fats placed on the market for the final consumer or for use as an ingredient in food. Because of the health concern for infants, toddlers and young children it is appropriate to establish a stricter maximum level for vegetable oils and fats destined for the production of baby food and processed cereal-based food for infants and young children. In order to exclude any possible health concerns as regards infants, toddlers and young children, in particular, taking into account the possible exposure to glycidyl fatty acid esters of infants solely fed on infant formula, it is appropriate to establish a specific strict maximum level for infant formula, follow-on formula and food for special medical purposes intended for infants and young children. However there is a need to further reduce the presence of glycidyl fatty acid esters in infant formula, follow-on formula and food for special medical purposes intended for infants and young children and therefore it is necessary to review the maximum levels once a reliable method of analysis is available to analyse stricter levels in view of ensuring an effective enforcement of these levels.

Scientific opinions

Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-007)

Pest categorisation of Aschistonyx eppoi

Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)-1-(3-(((4-amino-2,2-dioxido-1H-benzo[c][1,2,6]thiadiazin-5-yl)oxy)methyl)piperidin-1-yl)-3-methylbutan-1-one

Outcome of the Public Consultation on the draft Scientific Opinion on the state of the science on pesticide risk assessment for amphibians and reptiles

Scientific Opinion on the state of the science on pesticide risk assessment for amphibians and reptiles

Appropriateness to set a group health-based guidance value for fumonisins and their modified forms

Pest categorisation of Anisogramma anomala

Pest categorisation of Bretziella fagacearum

Safety in use of glucosylated steviol glycosides as a food additive in different food categories

Risks to human and animal health related to the presence of moniliformin in food and feed

Pest categorisation of Scirtothrips aurantii

Pest categorisation of Scirtothrips citri

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2016

Safety and efficacy of benzoic acid for pigs and poultry

Safety and efficacy of Zinc-l-Selenomethionine as feed additive for all animal species

Pest categorisation of Unaspis citri

Safety and efficacy of 3-phytase FLF1000 as a feed additive for chickens reared for laying and minor poultry species

Risks to human and animal health related to the presence of moniliformin in food and feed

Pest categorisation of Scirtothrips aurantii

Pest categorisation of Scirtothrips citri

Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives

Safety of vitamin B2 (80%) as riboflavin produced by Bacillus subtilis KCCM‐10445 for all animal species

Safety and efficacy of Coxiril® (diclazuril) for pheasants

Safety and efficacy of sodium saccharin when used as a feed flavour for piglets, pigs for fattening, calves for rearing and calves for fattening

Safety and efficacy of Sacox® microGranulate (salinomycin sodium) for rabbits for fattening

Safety and efficacy of hydroxy analogue of methionine and its calcium salt (ADRY+®) for all animal species

Efficacy of Cylactin® (Enterococcus faecium NCIMB 10415) as a feed additive for pigs for fattening

Safety and efficacy of Pediococcus pentosaceus DSM 32291 as a silage additive for all animal species

Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for minor poultry species for fattening and reared for laying

Safety and efficacy of natural mixtures of talc (steatite) and chlorite (E 560) as a feed additive for all animal species

Scientific Opinion on Flavouring Group Evaluation 74, Revision 4 (FGE.74Rev4): Consideration of aliphatic sulphides and thiols evaluated by JECFA (53rd and 61st meeting) structurally related to aliphatic and alicyclic mono-, di-, tri- and polysulphides

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